Valvular Heart Disease Clinical Trial
Official title:
Safety and Efficacy of the Gastric Reactance (XL) in the Prediction of Morbimortality in Patients Post-operated of Elective Cardiac Surgery
Evaluate the safety and effectiveness of the XL trend measured by Florence (Critical
Perfusion Inc, Palo Alto, California) in the prediction of morbimortality of Mexican patients
post-operated of elective cardiovascular surgery.
Hypothesis: 1. The gastric reactance measurement (XL) correlates with the morbimortality
(postoperatory shock, excessive bleeding, vasoplegic syndrome and death) and with the risk
predictors (APACHE II, STS, SOFA, and EUROSCORE II) with patients post-operated of elective
cardiac surgery. 2. It is possible to identify the cut-off point of the values of the gastric
reactance (XL) as a predictive tool of morbimortality in patients post-operated of elective
cardiac surgery. 3. The gastric reactance (XL) is a safe measurement to patients undergoing
cardiac surgery.
A maximum of 35 patients with age greater or equal to 18 years with elective surgery
(valvular surgery, revascularization, or a combination of both) that comply with the
inclusion/exclusion criteria of this protocol will be enrolled.
Investigational device: Florence (Gastric Impedance Spectrometer System or ISMO). Comparative
with Risk scales SOFA, APACHE II, STS, Euroscore II, hemodynamic variables, lactate and mixed
venous saturation.
The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in
ICU.
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